Hysterectomy model

ABSTRACT

A surgical simulator for surgical training is provided. The simulator includes a frame defining an enclosure and a simulated tissue model located inside the enclosure. The simulated tissue model is adapted for practicing a number of surgical procedures including but not limited to transanal excisions and transvaginal hysterectomies. The simulated tissue model includes one more components and is interchangeably connected to the frame with fasteners configured to pass through apertures in the frame to suspend the simulated tissue model within the frame. The enclosure of the frame is increasingly laterally constricted along the longitudinal axis to progressively increase the confinement of the components of the simulated tissue model.

CROSS-REFERENCE TO RELATED APPLICATION

This patent application is a continuation of International PatentApplication No. PCT/US2016/055148 entitled “Hysterectomy model” filed onOct. 3, 2016 which claims priority to and benefit of U.S. ProvisionalPatent Application Serial No. 62/236,756 entitled “Hysterectomy model”filed on Oct. 2, 2015 and U.S. Provisional Patent Application Serial No.62/254,477 entitled “Hysterectomy model” filed on Nov. 12, 2015incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

This application is generally related to surgical training tools, and inparticular, to simulated tissue structures and models for teaching andpracticing various surgical techniques and procedures related but notlimited to laparoscopic, endoscopic and minimally invasive surgery.

BACKGROUND OF THE INVENTION

Medical students as well as experienced doctors learning new surgicaltechniques must undergo extensive training before they are qualified toperform surgery on human patients. The training must teach propertechniques employing various medical devices for cutting, penetrating,clamping, grasping, stapling, cauterizing and suturing a variety oftissue types. The range of possibilities that a trainee may encounter isgreat. For example, different organs and patient anatomies and diseasesare presented. The thickness and consistency of the various tissuelayers will also vary from one part of the body to the next and from onepatient to another. Different procedures demand different skills.Furthermore, the trainee must practice techniques in various anatomicalenvirons that are influenced by factors such as the size and conditionof the patient, the adjacent anatomical landscape and the types oftargeted tissues and whether they are readily accessible or relativelyinaccessible.

Numerous teaching aids, trainers, simulators and model organs areavailable for one or more aspects of surgical training. However, thereis a need for models or simulated tissue elements that are likely to beencountered in and that can be used for practicing endoscopic andlaparoscopic, minimally invasive, transluminal surgical procedures. Inlaparoscopic surgery, a trocar or cannula is inserted to access a bodycavity and to create a channel for the insertion of a camera such as alaparoscope. The camera provides a live video feed capturing images thatare then displayed to the surgeon on one or more monitors. At least oneadditional small incision is made through which another trocar/cannulais inserted to create a pathway through which surgical instruments canbe passed for performing procedures observed on the monitor. Thetargeted tissue location such as the abdomen is typically enlarged bydelivering carbon dioxide gas to insufflate the body cavity and create aworking space large enough to accommodate the scope and instruments usedby the surgeon. The insufflation pressure in the tissue cavity ismaintained by using specialized trocars. Laparoscopic surgery offers anumber of advantages when compared with an open procedure. Theseadvantages include reduced pain, reduced blood and shorter recoverytimes due to smaller incisions.

Laparoscopic or endoscopic minimally invasive surgery requires anincreased level of skill compared to open surgery because the targettissue is not directly observed by the clinician. The target tissue isobserved on monitors displaying a portion of the surgical site that isaccessed through a small opening. Therefore, clinicians need to practicevisually determining tissue planes, three-dimensional depth perceptionon a two-dimensional viewing screen, hand-to-hand transfer ofinstruments, suturing, precision cutting and tissue and instrumentmanipulation. Typically, models simulating a particular anatomy orprocedure are placed in a simulated pelvic trainer where the anatomicalmodel is obscured from direct visualization by the practitioner. Portsin the trainer are employed for passing instruments to practicetechniques on the anatomical model hidden from direct visualization.Simulated pelvic trainers provide a functional, inexpensive andpractical means to train surgeons and residents the basic skills andtypical techniques used in laparoscopic surgery such as grasping,manipulating, cutting, tying knots, suturing, stapling, cauterizing aswell as how to perform specific surgical procedures that utilized thesebasic skills. Simulated pelvic trainers are also effective sales toolsfor demonstrating medical devices required to perform these laparoscopicprocedures.

One procedure is a hysterectomy in which the uterus is removed. Thehysterectomy may be performed vaginally extracting the uterus throughthe vaginal canal or abdominally through a small incision in theabdomen. The vaginal hysterectomy is historically hard to train on asthe field of view is limited. Unlike laparoscopic procedures, there isno camera that is projecting the surgery onto a screen and unlike openprocedures there is not a wide incision that can be viewed by multiplepeople. As such, the best way to teach a vaginal hysterectomy is througha simulated model. Therefore, there is a need for model for traininghysterectomy procedures.

SUMMARY OF THE INVENTION

According to one aspect of the invention, a surgical simulator forsurgical training is provided. The surgical simulator includes a framehaving an inner surface and an outer surface defining a frame walltherebetween. The inner surface defines a lumen extending along alongitudinal axis of the frame. The lumen includes at least one of aproximal opening and a distal opening. The frame is configured toremovably receive at least one artificial tissue structure within thelumen such that the at least one artificial tissue structure is at leastpartially suspended within the lumen and at least partially encompassedby the frame wall along the lumen. The at least one artificial tissuestructure is suspended with fasteners configured to connect the at leastone artificial tissue structure to the frame wall. The lumen has across-sectional area taken perpendicular to the longitudinal axis thatprogressively increases from the proximal end to the distal end.

According to another aspect of the invention, a surgical simulator forsurgical training is provided. The frame includes an inner surface andan outer surface defining a frame wall therebetween. The inner surfacedefines a lumen extending along the longitudinal axis. The lumen has atleast one of a proximal opening and a distal opening and a top and abottom. The surgical simulator further includes an artificial uterus andan artificial vaginal canal defining an opening at the proximal end andconnected to the artificial uterus at the distal end. The surgicalsimulator further includes an artificial rectum having a lumen defininga proximal opening. The surgical simulator further includes anartificial bladder. The surgical simulator further includes anartificial bladder. The surgical simulator further includes a firstplanar sheet of silicone having a first surface and a second surfacedefining a substantially uniform thickness therebetween. The surgicalsimulator further includes a second planar sheet of silicone having afirst surface and a second surface. The artificial uterus, artificialvaginal canal, and artificial bladder are connected to the first surfaceof the first planar sheet and the first planar sheet is connected to thetop of the lumen. The artificial uterus and artificial vaginal canal areconnected to the artificial rectum by the second planar sheet. Theartificial rectum is connected to the bottom of the frame.

According to another aspect of the invention, an artificial uterus forsurgical training is provided. The artificial uterus includes a bulbousbody at a distal end and a simulated cervix at a proximal end. Thesimulated cervix is made of silicone and defines an opening at theproximal end. The simulated cervix includes a reinforcement made of meshmaterial. The mesh material has a plurality of interwoven filamentsforming a tubular structure having a first end and a second end. Thetubular structure forms a first layer of mesh material and is folded tocreate a second layer of mesh material. The fold is formed at a proximalend such that the first end and the second end of the tubular structureare distal to the fold. The second layer of mesh material issubstantially coaxial with the tubular first layer of mesh material. Thefolded tubular structure is embedded in silicone of the simulated cervixat the proximal end.

A surgical simulator for surgical training is provided. The simulatorincludes a frame defining an enclosure and a simulated tissue modellocated inside the enclosure. The simulated tissue model is adapted forpracticing a number of surgical procedures including but not limited totransanal excisions and transvaginal hysterectomies. The simulatedtissue model includes one more components and is interchangeablyconnected to the frame with fasteners configured to pass throughapertures in the frame to suspend the simulated tissue model within theframe. The enclosure of the frame is increasingly laterally constrictedalong the longitudinal axis to progressively increase the confinement ofthe components of the simulated tissue model.

According to another aspect of the invention, a surgical simulator forsurgical training is provided. The surgical simulator includes a rigidframe having an inner surface and an outer surface defining a frame walltherebetween. The inner surface defines a passageway extending along alongitudinal axis. The passageway has at least one of a proximal openingand a distal opening. An artificial tissue structure made of silicone isprovided and at least one fastener is connected to the artificial tissuestructure. The at least one fastener is configured to removably connectthe artificial tissue structure to the frame. The frame includes one ormore apertures and the fasteners are configured to pass through the oneor more apertures to connect the artificial tissue structure to theframe.

According to another aspect of the invention, a surgical simulator forsurgical training is provided. The simulator includes a frame definingan enclosure and a simulated tissue model located inside the enclosure.The simulated tissue model is adapted for practicing a number ofsurgical procedures including but not limited to transanal excisions,transvaginal hysterectomies, and other laparoscopic, minimally invasiveand open procedures. The simulated tissue model includes one morecomponents. The model is interchangeably connected to the frame withfasteners configured to pass through apertures in the frame to suspendthe simulated tissue model within the frame. The enclosure of the frameis increasingly laterally constricted along the longitudinal axis toprogressively increase the confinement of the components of thesimulated tissue model. The increased confinement provides reducedpendulation of the model components.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top perspective view of a surgical training device accordingto the present invention.

FIG. 2 is an antero-cephalad, top perspective view of a model accordingto the present invention.

FIG. 3A is a top perspective view of a pelvic frame according to thepresent invention.

FIG. 3B is a top perspective view of a pelvic frame according to thepresent invention.

FIG. 3C is a top perspective view of a pelvic frame according to thepresent invention.

FIG. 3D is a top view of a pelvic frame in a flat orientation accordingto the present invention.

FIG. 4A is a caudal end view of a model inside a surgical trainingdevice according to the present invention.

FIG. 4B is a lateral side view of a model inside a surgical trainingdevice according to the present invention.

FIG. 4C is a lateral side view of a model inside a surgical trainingdevice according to the present invention.

FIG. 4D is an antero-caudal, top perspective view of a model inside asurgical training device according to the present invention.

FIG. 4E is a cephalad end view of a model inside a surgical trainingdevice according to the present invention.

FIG. 5A is a side view of a transvaginal adapter according to thepresent invention.

FIG. 5B is a top perspective view of a transvaginal adapter according tothe present invention.

FIG. 6A is a side view of a transvaginal adapter according to thepresent invention.

FIG. 6B is a top perspective view of a transvaginal adapter according tothe present invention.

FIG. 7 is a top perspective view of a hysterectomy model according tothe present invention.

FIG. 8 is a top perspective, partially transparent view of ahysterectomy model according to the present invention.

FIG. 9 is a top perspective view of a frame of a hysterectomy modelaccording to the present invention.

FIG. 10 is a top planar view of a top frame portion of a hysterectomymodel according to the present invention.

FIG. 11 is a top perspective view of a top frame portion in a foldedconfiguration according to the present invention.

FIG. 12 is a top planar view of a bottom frame portion of a hysterectomymodel according to the present invention.

FIG. 13 is a top perspective view of a bottom frame portion in a foldedconfiguration according to the present invention.

FIG. 14 is a side elevational, partial cross-sectional view of ahysterectomy model according to the present invention.

FIG. 15 is a side elevational, exploded view of a hysterectomy modelaccording to the present invention.

FIG. 16 is an exploded view of a fastener according to the presentinvention.

FIG. 17 is a front perspective view of a transvaginal adapter with anovermolded soft simulated vaginal tissue interface according to thepresent invention.

FIG. 18 is a back perspective view of a transvaginal adapter with anovermolded soft simulated vaginal tissue interface according to thepresent invention.

FIG. 19 is a top perspective view of a mold according to the presentinvention.

FIG. 20 is a top perspective view of a mold and a silicone tube placedover a center post of the mold according to the present invention.

FIG. 21 is a top perspective view of a mold, a silicone tube placed overa center post and a silicone outer interface formed in the moldaccording to the present invention.

FIG. 22 is a cross-sectional view of a mold, a silicone tube placed overa center post and a silicone outer interface formed in the moldaccording to the present invention.

FIG. 23 is a top perspective view of a mold, a silicone tube placed overa center post, a silicone outer interface formed in the mold and a flatplate according to the present invention.

FIG. 24 is a cross-sectional view of a mold, a silicone tube placed overa center post, a silicone outer interface formed in the mold and a flatplate according to the present invention.

FIG. 25 is a top perspective view of a mold, a silicone tube placed overa center post, a silicone outer interface formed in the mold, a flatplate and a backing mold according to the present invention.

FIG. 26 is a cross-sectional view of a mold, a silicone tube placed overa center post, a silicone outer interface formed in the mold, a flatplate and a backing mold according to the present invention.

FIG. 27 is a top perspective view of a mold, a silicone tube placed overa center post, a silicone outer interface formed in the mold, a flatplate, a backing mold and a silicone inner interface according to thepresent invention.

FIG. 28 is a cross-sectional view of a mold, a silicone tube placed overa center post, a silicone outer interface formed in the mold, a flatplate, a backing mold and a silicone inner interface according to thepresent invention.

FIG. 29 is a side elevational, partial cross-sectional view of ahysterectomy model according to the present invention.

FIG. 30 is a side elevational, exploded view of a hysterectomy modelaccording to the present invention.

FIG. 31 is a top perspective view of a frame according to the presentinvention.

FIG. 32 is a top perspective view of a mesh inside an open uterine moldand a mandrel according to the present invention.

FIG. 33 is a top perspective view of mesh and silicone inside an openuterine mold according to the present invention.

FIG. 34 is a top perspective view of mesh and silicone inside an openuterine mold according to the present invention.

FIG. 35 is a top perspective view of a mesh, silicone and a mandrelinside an open uterine mold according to the present invention.

FIG. 36A is a top perspective view of mesh, silicone and a mandrelinside a closed uterine mold according to the present invention.

FIG. 36B is a top perspective view of a plurality of closed and clampeduterine molds according to the present invention.

FIG. 37 is a top perspective view of a cervix mold according to thepresent invention.

FIG. 38A is a top perspective view of a folded fabric sleeve accordingto the present invention.

FIG. 38B is a top perspective view of a tubular sleeve being folded untoitself to create a folded sleeve having two layers of fabric accordingto the present invention.

FIG. 39 is a top perspective view of a post inside a fabric sleeveaccording to the present invention.

FIG. 40 is a top perspective view of a post inside a fabric sleeveinside a well of a cervix mold according to the present invention.

FIG. 41A is a top perspective view of uncured silicone being poured intoa cervix mold according to the present invention.

FIG. 41 B is a cross-sectional view of a folded sleeve with a postinside a well of a cervix mold according to the present invention.

FIG. 42 is a top perspective view of a post inside a fabric sleeveinside a well of a cervix mold partially filled with uncured siliconeand a uterine form being squeezed according to the present invention.

FIG. 43 is a top perspective view of a uterine form being inserted intoa well of a cervix mold while being squeezed according to the presentinvention.

FIG. 44 is a top perspective view of a uterine form inside a well of acervix mold according to the present invention.

FIG. 45 is a top perspective view of a simulated uterus with a postaccording to the present invention.

FIG. 46A is a proximal end view of a simulated uterus according to thepresent invention.

FIG. 46B is a top perspective, sectional view of a proximal end of asimulated uterus according to the present invention.

FIG. 47 is a top perspective view of a pair of mesh socks attached to apair of mandrels according to the present invention.

FIG. 48 is a top perspective view of simulated vaginal canal with anembedded mesh layer according to the present invention.

FIG. 49 is a top perspective view of a distal end of a simulated vaginalcanal according to the present invention.

FIG. 50 is a top perspective view of a distal end of a simulated vaginalcanal according to the present invention.

FIG. 51 is a top perspective view of an inverted simulated vaginal canalaccording to the present invention.

FIG. 52 is a proximal end view of simulated vaginal canal according tothe present invention.

FIG. 53 is a top view of silicone vessel located across an ovary moldaccording to the present invention.

FIG. 54 is a top view of a silicone vessel located across an ovary moldaccording to the present invention.

FIG. 55 is a top perspective view of a transvaginal adapter according tothe present invention.

FIG. 56 is a top perspective sectional view of a transvaginal adapteraccording to the present invention.

FIG. 57 is an end view of a transvaginal adapter according to thepresent invention.

FIG. 58 is a side view of a transvaginal adapter according to thepresent invention.

FIG. 59 is an end view of a simulated uterus connected to a transvaginaladapter that is connected between a top cover and a base of surgicaltrainer is a top perspective view of a transvaginal adapter according tothe present invention.

DETAILED DESCRIPTION OF THE INVENTION

A surgical training device 10 that is configured to mimic the torso of apatient such as the abdominal region is shown in FIG. 1. The surgicaltraining device 10 provides a body cavity 12 substantially obscured fromthe user for receiving simulated or live tissue or model organs ortraining models of the like described in this invention. The body cavity12 is accessed via a tissue simulation region 14 that is penetrated bythe user employing devices to practice surgical techniques on the tissueor practice model found located in the body cavity 12. Although the bodycavity 12 is shown to be accessible through a tissue simulation region,a hand-assisted access device or single-site port device may bealternatively employed to access the body cavity 12. An exemplarysurgical training device is described in U.S. patent application Ser.No. 13/248,449 entitled “Portable Laparoscopic Trainer” filed on Sep.29, 2011 and incorporated herein by reference in its entirety. Thesurgical training device 10 is particularly well suited for practicinglaparoscopic or other minimally invasive surgical procedures.

Still referencing FIG. 1, the surgical training device 10 includes a topcover 16 connected to and spaced apart from a base 18 by at least oneleg 20. FIG. 1 shows a plurality of legs 20. The surgical trainingdevice 10 is configured to mimic the torso of a patient such as theabdominal region. The top cover 16 is representative of the anteriorsurface of the patient and the space 12 between the top cover 16 and thebase 18 is representative of an interior of the patient or body cavitywhere organs reside. The surgical trainer 10 is a useful tool forteaching, practicing and demonstrating various surgical procedures andtheir related instruments in simulation of a patient undergoing asurgical procedure. Surgical instruments are inserted into the cavity 12through the tissue simulation region 14 as well as throughpre-established apertures 22 in the top cover 16. Various tools andtechniques may be used to penetrate the top cover 16 to perform mockprocedures on simulated organs or practice models placed between the topcover 16 and the base 18. The base 18 includes a model-receiving area 24or tray for staging or holding a simulated tissue model or live tissue.The model-receiving area 24 of the base 18 includes frame-like elementsfor holding the model (not shown) in place. To help retain a simulatedtissue model or live organs on the base 18, a clip attached to aretractable wire is provided at locations 26. The retractable wire isextended and then clipped to hold the tissue model in positionsubstantially beneath the tissue simulation region 14. Other means forretaining the tissue model include a patch of hook-and-loop typefastening material (VELCRO®) affixed to the base 18 in the modelreceiving area 24 such that it is removably connectable to acomplementary piece of hook-and-loop type fastening material (VELCRO®)affixed to the model.

A video display monitor 28 that is hinged to the top cover 16 is shownin a closed orientation in FIG. 1. The video monitor 28 is connectableto a variety of visual systems for delivering an image to the monitor.For example, a laparoscope inserted through one of the pre-establishedapertures 22 or a webcam located in the cavity and used to observe thesimulated procedure can be connected to the video monitor 28 and/or amobile computing device to provide an image to the user. Also, audiorecording or delivery means may also be provided and integrated with thetrainer 10 to provide audio and visual capabilities. Means forconnecting a portable memory storage device such as a flash drive, smartphone, digital audio or video player, or other digital mobile device isalso provided, to record training procedures and/or play backpre-recorded videos on the monitor for demonstration purposes. Ofcourse, connection means for providing an audio visual output to ascreen larger than the monitor is provided. In another variation, thetop cover 10 does not include a video display but includes means forconnecting with a laptop computer, a mobile digital device or tablet andconnecting it by wire or wirelessly to the trainer.

When assembled, the top cover 16 is positioned directly above the base18 with the legs 20 located substantially around the periphery andinterconnected between the top cover 16 and base 18. The top cover 16and base 18 are substantially the same shape and size and havesubstantially the same peripheral outline. The internal cavity ispartially or entirely obscured from view. In the variation shown in FIG.1, the legs include openings to allow ambient light to illuminate theinternal cavity as much as possible and also to advantageously provideas much weight reduction as possible for convenient portability. The topcover 16 is removable from the legs 20 which in turn are removable orcollapsible via hinges or the like with respect to the base 18.Therefore, the unassembled trainer 10 has a reduced height that makesfor easier portability. In essence, the surgical trainer 10 provides asimulated body cavity 12 that is obscured from the user. The body cavity12 is configured to receive at least one surgical model accessible viaat least one tissue simulation region 14 and/or apertures 22 in the topcover 16 through which the user may access the models to practicelaparoscopic or endoscopic minimally invasive surgical techniques.

A model 30 for practicing hysterectomies and, in particular, forpracticing vaginal hysterectomies according to the present invention isshown in FIG. 2. The model 30 is configured to be placed inside thesurgical training device 10 described above or other similar surgicaltrainer. The model 30 includes a simulated uterus 32 connected to aframe 34 with a first sheet 36 and a second sheet 38. The simulateduterus 32 includes a bulbous portion 40 defining a hollow simulateduterine cavity 42. The bulbous portion 40 is connected to a tubularportion 44 defining a vaginal canal 46 having an opening 48. Thesimulated uterus 32 further includes a simulated cervix 50 (shown inFIG. 4A) located inside the simulated uterus 32 in a locationsubstantially between the uterine cavity 42 and the vaginal canal 46.The simulated cervix 50 includes a slit 52. The simulated cervix 50 ismade of a solid, high durometer silicone.

The simulated uterus 32 further includes simulated fallopian tubes 54connected to ovaries 56. The simulated uterus 32, fallopian tubes 54 andovaries 56 are made of silicone or other elastomeric material and mayinclude other material such as foam material combined with the silicone.The simulated uterus 32 is made of silicone or lighter foam such asurethane or silicone foam or a combination of the two. The siliconeconstruction imparts the simulated uterus 32 with a more realisticweight when the attached simulated cervix 50 is being pulled andmanipulated. The simulated uterus 32 made of foam makes the simulateduterus 32 easier to suspend inside the simulated pelvic cavity. Also,when removing the simulated uterus 32 the lightweight foam flexes moreeasily than a simulated uterus 32 made of higher durometer siliconeallowing a larger simulated uterus 32 to be placed into the model 30 andstill be removed. The foam uterus 32 would compress and flex as it isbeing removed through the vaginal opening 48 similar to an actualsurgery. The simulated uterus 32 is approximately 300-500 grams and thesimulated uterus 32 is composed of a selected durometer foam toaccurately represent the size and weight of a real uterus that couldnormally be removed vaginally without significant morcellation. The useof foam for the artificial uterus provides a realistic resistance duringvaginal hysterectomy, proper bulk density and realistic morcellationproperties along with an overall muscular-like feel without collapsingduring removal. In another variation, the simulated uterus 32 is acombination of silicone and foam to give a more realistic look to thesimulated uterus 32 while still having the flexibility of the foam. Thefoam can be cast and then the silicone can be applied over the foam suchas, for example, on a rotational mold in an over-molding method. Thisvariation advantageously results in not having to put mesh reinforcementalong the entire length of the artificial uterus and allows theartificial uterus to be manipulated while having a smooth realisticfinish that permits the color to be changed by using different coloredsilicone and/or foam. The simulated uterus 32 is generally pink in colorand the fallopian tubes 54 and ovaries are clear or white in color.Furthermore, the simulated uterus 32 may include embedded tumors, cystsand/or ectopic pregnancies in the fallopian tubes 54. The model 30 mayfurther include simulated vasculature 58 such as blood vessels. Thesimulated vasculature 58 is made of solid or hollow tubular silicone orother suitable elastomer. Liquid may be included inside the hollowtubing of the simulated vasculature 58. The simulated vasculature 58that simulates blood vessels may be red in color. The model 30 may alsoinclude simulated ligaments 59 such as the uteralsacral ligament 59 andmade of silicone material as seen in FIGS. 2 and 4E. The model 30 mayfurther include the round and tubo ovarian ligaments 61 attached to theframe 34 shown in FIG. 2.

With additional reference to FIGS. 3A-3D, the frame 34 comprises acylindrical-like shape defining an interior/lumen 60. The frame 34includes a first surface 62 interconnected to a second surface 64defining a thickness therebetween. The first surface 62 defines theinner surface of the cylindrical-like shape of the frame 34 and thesecond surface 64 defines an outer surface of the cylindrical-like shapeof the frame 34. The frame 34 is made of flexible foam material that isalso slightly compressible. The frame 34 includes one or more cutouts 66extending between the first surface 62 and the second surface 64 todefine an outer perimeter and apertures. In one variation, the frame 34is made of a sheet of foam material that is cut according to a patternshown in FIG. 3D. FIG. 3D illustrates the outer perimeter having a top68 and a bottom 70 interconnected by a first side and a second side 72,74. The top 68 includes two curved portions 76 a, 76 b interconnected ata first protrusion 78 along a vertical axis. The two curved portions 76a, 76 b represent the left and right illium/iliac crest. The bottom 70includes a second protrusion 80 along the vertical axis. The firstprotrusion 78 represents the sacrum of a human pelvis and the secondprotrusion 80 represents the coccyx. The first side 72 includes a firstlower lobe 82 having a first aperture 86 and the second side 74 includesa second lower lobe 84 having a second aperture 88. The first and secondlower lobes 82, 84 represent the left and right ischium and the firstaperture 86 and the second aperture 88 represent the obturator foramenof the human pelvis. A piece of foam having a thickness is cut to havethe flat pattern shape shown in FIG. 3D. Then the piece of foam iscurved such that the first lower lobe 82 and second lower lobe 84 jointogether in a cylinder-like configuration. Where the two lobes 82, 84are joined, represent the pubic bone/pubis/pubis symphysis. The twolobes 82, 84 can be joined by adhesive or connected in another suitablemanner. In another variation, the two lobes 82, 84 are not joinedtogether but remain spaced apart in a semi-cylindrical-like or splitcylinder configuration. The frame 34 is bendable and may be made of amaterial that retains its shape after bending such as aluminum. Also,the clips 26 and wire that are connected to the trainer 10 may be usedto hold the two lobes 82, 84 in an upward orientation and in acylindrical-like configuration while inside the trainer 10. The anatomyof the pelvis is shown in FIG. 7.

The frame 34 is made of soft, compressible, semi-rigid foam that can bedie cut and then formed into the correct shape with adhesive. If theframe 34 is made of harder plastic, it could be a thin thermoform thatis initially formed into the correct shape or a thicker plastic that iscut into the pelvis shape and then formed into a cylindrical shape withheat. The frame 34 may also be made of deformable metal that holds itsshape. The frame 34 is not a perfect replica of the anatomy and needonly include certain features selected to practice certain proceduresthat require those specific features as anatomical reference points orvisual landmarks for the practitioner. For example, for practicing avaginal hysterectomy, the important features of the pelvis are therestriction of the pelvic inlet and the attachments to the pelvicsidewall. For practicing a transanal total mesorectal excision (taTME),the L-shape of the sacrum is an important landmark. For herniaprocedures, the pubic tubercle is an important landmark. The frame 34can be made to have all anatomically correct features or only the onesneeded for the specific procedure. As such, the frame 34 and model 30can be used for the simulation of a vaginal hysterectomy, abdominalhysterectomy, colectomy, hernia, taTME, and other pelvic procedures. Inanother variation, the frame 34 forms a conical shape or frusto-conicalshape having an open proximal and open distal ends.

With reference back to FIG. 2, the model 30 may further include asimulated bladder 90. The simulated bladder 90 is a hollow, air-filledcomponent typically made of silicone or other elastomeric material. Inanother variation, the simulated bladder contains liquid. The simulatedbladder 90 is connected to the frame 34 with adhesive or other means. Itis connected to the first surface 62 or inner surface of the frame 34.The simulated bladder 90 is attached in alignment with the vertical axisin the location of where the two lobes 82, 84 are in juxtaposition in alocation representative of the pubis. When connected the simulatedbladder 90 extends into the lumen 60 of the frame 34. The simulatedbladder 90 may further include a simulated ureter 94. In one variation,the simulated ureter 94 is connected to the simulated bladder 90. Thesimulated ureter is made of solid or hollow tubular silicone.

Still referencing FIG. 2, the model 30 may further include a simulatedcolon 92 or bowel portion. The simulated colon 92 is a tubular structurethat includes a lumen. The simulated colon 92 is laid on the firstsurface 62 inside the interior 60 of the frame 34 and substantiallyalong the vertical axis and against the second protrusion 80 of theframe 34. Adhesive may be used to attach the simulated colon 92 to theframe 34. The simulated colon 92 is made of silicone or other suitableelastomeric material and colored pink or other suitable color and may ormay not include simulated tumors.

The first sheet 36 is a thin layer of clear silicone material having atop surface 96 and a bottom surface 98 and a first end 100 and a secondend 102. The first sheet 36 is transparent and at least one of the topsurface 96 and the bottom surface 98 is textured in one variation. Thefirst sheet 36 is attached to the simulated uterus 32. In particular,the bottom surface 98 of the first sheet 36 near the first end 100 isattached along at least a portion of the length of simulated uterus 32to one or more of the bulbous portion 40 and tubular portion 44 as shownin FIG. 2. The first sheet 36 is then folded back toward the top of themodel 30 and toward the first end 100 of the first sheet 36 creating afold near the tubular portion 44 of the simulated uterus 32. At least aportion of the first sheet 36 near the second end 102 of the first sheet36 is attached to the frame 34 such that the bottom surface 98 of thefirst sheet 36 is adhered to the frame 34 in the general location ofwhere the two lobes 82, 84 are in juxtaposition to create acylinder-like configuration for the frame 34. The attachment of thefirst sheet 36 may also serve to hold the frame 34 in thecylindrical-like configuration. Adhesive is used to attach the bottomsurface 98 of the first sheet 36 to the frame 34. The bottom surface 98of the first sheet 36 is attached to the first surface 62 or innersurface of the frame 34 and then folded around a portion of the firstside 72 and second side 74 of the frame 34. If a simulated bladder 90 isemployed in the model 30, then the second end 102 of the first sheet 36is also attached with adhesive to the outer surface of the simulatedbladder 90 capturing the simulated bladder 90 between the frame 34 andthe first sheet 36. A portion of the second end 102 of the first sheet36 is folded around the edge of the frame 34 and attached to the secondsurface 64 of the frame 34 such that at least part of the second end 102of the first sheet 36 is resident above the second or outer surface 64of the frame 34 as visible in FIG. 4D. The first sheet 36 is sized andconfigured to suspend the simulated uterus 32 inside the interior 60 ofthe frame 34. Simulated vasculature 58 may be attached to the topsurface 96 or bottom surface 98 of the first sheet 36. The configurationof the first sheet 36 forms a pocket-like structure wherein the topsurface 96 of the first sheet 36 is folded and at least in part facingitself. The first sheet 36 creates a webbing of suspension thatsimulates the peritoneum layer.

The second sheet 38 is a thin layer of clear silicone material having atop surface 104 and a bottom surface 106 and a first end 108 and asecond end 110. The second sheet 38 is transparent and at least one ofthe top surface 104 and the bottom surface 106 is textured in onevariation. The second sheet 38 is attached to the simulated uterus 32.In particular, the bottom surface 106 of the second sheet 38 near thefirst end 108 is attached along at least a portion of the length ofsimulated uterus 32 to one or more of the bulbous portion 40 and tubularportion 44 on a side opposite from where the first sheet 36 is attached.The first sheet 36 is attached to the anterior side of the model 30which is also the anterior side of the simulated uterus 32. The secondsheet 38 is attached to the posterior side of the model 30 which is alsothe posterior side of the simulated uterus 32. After being attached tothe posterior side of the simulated uterus 32, the second sheet 38 isthen folded back toward the top of the model 30 and toward the first end108 of the second sheet 38 creating a fold near the tubular portion 44of the simulated uterus 32. At least a portion of the second sheet 38near the second end 110 of the second sheet 38 is attached to the frame34 such that the bottom surface 106 of the second sheet 38 is adhered tothe frame 34 in the general location of the second protrusion 80.Adhesive is used to attach the bottom surface 106 of the second sheet 38to the frame 34. The bottom surface 106 of the second sheet 38 isattached to the first surface 62 or inner surface of the frame 34 andmay be folded around the edge of the frame 34 such that at least part ofthe second end 110 of the second sheet 38 is connected to second orouter surface 64 of the frame 34. If a simulated colon 92 is employed inthe model 30, then the second end 110 of the second sheet 38 is alsoattached with adhesive to the outer surface of the simulated colon 92 orat least overlaying and not attached with adhesive such that at least aportion of the simulated colon 92 is captured or located between theframe 34 and the second sheet 38. The second sheet 38 is sized andconfigured to suspend the simulated uterus 32 inside the interior 60 ofthe frame 34 if the model 30 is turned over. Simulated vasculature 58may be attached to the top surface 104 or bottom surface 106 of thesecond sheet 38. The configuration of the second sheet 38 forms apocket-like structure wherein the top surface 104 of the second sheet 38is folded and at least in part facing itself. The second sheet 38creates a suspended webbing that simulates the peritoneum layer.

With reference now to FIGS. 4A-4E, the model 30 is shown placed inside asurgical training device 10 of the like described with respect toFIG. 1. The model 30 is shown inside the body cavity 12 and orientedsuch that the top 68 of the frame 34 is in the cephalad direction of thesimulated training device 10 and the vaginal opening 48 of the simulateduterus 32 faces the caudal direction of the simulated training device10. The model 30 can be connected to the surgical training device 10with the clips 26 attached to the trainer 10. The retractable clips 26can be pulled out and the clips 26 attached to any portion of the model30 such as to the frame 34 of the model 30. Also, the second or outersurface 64 of the model 30 may include a hook-and-loop type fastenerconfigured to attach to a complementary portion of hook-and-loop typefastener connected to the base 18 of the trainer 10. Together with oneor more fasteners such as the clips 26 and/or hook-and-loop typefasteners, the model 30 is securely attached to the trainer 10 such thatit can be manipulated in simulated surgery without dislodging the model30 from the body cavity 12 of the trainer 10. The model 30 is furtherconnected to the trainer 10 via a transvaginal adapter 112 that is sizedand configured to connect between the top cover 16 and the base 18 as anadditional leg 20 positioned at the caudal direction of the surgicaltraining device 10.

Turning now to FIGS. 5A-5B and 6A-6B, there is shown a transvaginaladapter 112. With reference also back to FIG. 1, there is shown a topcover supported above the base by five legs 20. In one variation, asixth leg 20 is provided as shown in FIGS. 4A-4D in the form of thetransvaginal adapter 112. The trainer 10 may be assembled with anoptional sixth support structure or leg which is configured forsimulating transvaginal surgery including transvaginal hysterectomies.

The transvaginal adapter 112 includes a flat plate 114 having an innersurface 116 for facing toward the interior of the trainer and an outersurface 118 for facing outwardly towards the user. The plate 114 has arectangular shape and includes an aperture 120 passing through the plate108 from the inner surface 116 to the outer surface 118. In onevariation, the aperture 120 is circular in shape. In another variation,the aperture 120 is elongate elliptical oval-like in shape and orientedvertically along the longitudinal axis of the adapter 112. In anothervariation, the aperture 120 is elongate elliptical oval-like in shapeand oriented perpendicularly to the longitudinal axis of the adapter. Asshown in FIGS. 5A-6B, the plate 114 also includes means such as tabs 122or a U-shaped channel for inserting to connect the transvaginal adapter112 to the top cover 16 and to the base 18 to help support and spaceapart the top cover 16. The transvaginal adapter 112 is located betweenthe top cover 16 and the base 18 and provides a side access aperture 16lateral to the trainer 10 or substantially perpendicular to the topcover 16 and the base 18. The plate 114 further includes a plurality ofmolding apertures 124 surrounding or encompassing the main aperture 120configured for overmolding a soft simulated vaginal tissue interfacemade of silicone or the like. In another variation the interface isinsertable into the aperture 120 of the transvaginal adapter 112. Thetissue interface (not shown) includes an aperture that is substantiallycoaxial with the plate aperture 120. At the inner surface of thetransvaginal adapter 112, a tubular extension 126 is integrally providedand extends into the simulated body cavity 12 of the trainer 10. Thetubular extension 126 is longer in FIGS. 6A-6B in comparison to thetubular extension 126 of FIGS. 5A-5B. The tubular extension 126 is sizedand configured such that the tubular portion 44 of the simulated uterus32 can be stretched around the extension 126 and secured to thetransvaginal adapter 112 such that the vaginal canal 46 is supported inan open configuration, coincident with and accessible through theaperture 120 of the adapter 112 as shown in FIGS. 4A-4D. The tubularextension 126 serves as a connector connecting the model 30 with thetrainer 10 in a manner that permits the interior of the uterus to beaccessed as in real surgery. In one variation, the tubular extension 126is a cylindrically-shaped extension having a radially-extending distalflange 128 that extends around at least a portion of the extension 128to help secure and retain the model 30 attached to the trainer 10. Thetubular portion 44 of the model 20 is attached to the tubular extension126 by pulling the tubular portion 44 over the distal flange 128, if oneis provided, and over and around the tubular extension 126 the outerdiameter of which is the same or slightly larger than the relaxed innerdiameter of the tubular portion 126 to keep the tubular portion 44secured to the transvaginal adapter 112. The transvaginal adapter 112can be made of flexible or rigid material. If the adapter 112 is made ofrigid material it will tend to simulate an already retracted vaginalcanal 46. If the adapter 112 is made of flexible material or softmaterial, the adapter 112 is suited for practicing retraction. Inanother variation, the transvaginal adapter 112 has a tubular extension126 that is made of soft flexible material and plate 114 made of rigidmaterial or surrounded by rigid material to keep the top cover 16 of thetrainer 10 supported which would still allow the practitioner topractice retraction at the opening of the vaginal canal 46 at theadapter 112.

In use, the model 30 is placed inside the surgical training device 10and held in place with a hook-and-loop type fastener and/or retractingclips 26. The tubular portion 44 is attached to the transvaginal adapter112 by stretching the vaginal opening 48 over the tubular extension 126of the adapter 112. A curtain may be employed that is placed around thesides of the trainer 30 to further conceal the model 30 such that theonly visualization is through the simulated vaginal canal 46. Thevaginal canal 46 is then retracted using a surgical retractor. Thevaginal canal 46 is made of a flexible thermoplastic elastomer (TPE).The TPE provides resistance as it is retracted and wants to spring backto its original shape which permits the user to practice realisticretraction. The transvaginal adapter 112 of FIGS. 6A-6B having a longertubular extension 126 is used to simulate an already retracted vaginalcanal. Hence, the transvaginal adapter 112 permits the practitioner topractice the hysterectomy procedure without needing extra-hands andassistance to perform the retraction. If the transvaginal adapter 112 ofFIGS. 5A-5B having the shorter tubular extension 126 is used, thepractitioner will practice retracting the vaginal canal 46 withretractors and the help of extra hands during the procedure. Thetransvaginal adapter 112 can be made of rigid or flexible material orrigid and flexible material as described above and selected for thepurpose of practicing retraction of the vaginal canal 46 or not. Next,the simulated cervix 50 is grasped and pulled towards the opening 48 ofthe vaginal canal 46. The simulated cervix 50 is made of high durometersilicone relative to the surrounding tubular portion 44. The simulatedcervix 50 is also made as a solid component which allows it to begrasped with real surgical tools and pulled on without fear of thesilicone ripping or tearing. The simulated cervix 50 is incisedcircumferentially and the practitioner is able to practice carefullydissecting the vaginal mucosa off of the simulated cervix 50. A sheet ofcotton or other webbing-like substance can be included in the model 30between the vaginal canal 46 and the simulated bladder 90. As describedabove, the simulated bladder 90 is a hollow, air-filled component. Ifthe practitioner cuts to high while dissecting the simulated vaginalmucosa and the simulated bladder 90 is accidentally incised, thesimulated bladder 90 could pop and give immediate feedback to thepractitioner especially if the simulated bladder 90 contains fluid.

The model 30 advantageously includes a second sheet 38 forming a foldbetween the simulated uterus 32 and the frame 34. Also, the suspensionof the simulated uterus 32 within the frame 34 advantageously creates arealistic response when the simulated uterus 32 is being incised andmanipulated. Also, in the variation in which the simulated uterus ismade of lighter foam material, the simulated uterus will remainsuspended, hang and swing in response to being manipulated with surgicalinstruments. At least portions of the simulated uterus and simulatedvagina are held in suspension inside the enclosure defined by the pelvicframe and connected thereto or directly connected to the enclosuredefined by the trainer. The suspension advantageously permits the foldof the second sheet to be accessed to practice posterior colpotomy intothe posterior cul-de-sac incision by incising the peritoneum forming therecto-uterine fold. The suspended simulated uterus 32 allows for theexistence of the recto-uterine peritoneum fold. As previously described,the simulated uterus 32 is pendent inside the frame 34 made of foammaterial that mimics a human pelvis. The simulated uterus 32 issuspended by a folded first sheet of silicone material on the anteriorside of the simulated uterus 32 and a folded second sheet of siliconematerial on the posterior side of the simulated uterus 32. The frame 34can be made of any material such as plastic or harder foam material. Theframe 34 serves as an attachment area for the various simulated portionsof the anatomy including the broad ligament, ovaries 56 and fallopiantubes 54. The elasticity of the silicone of these anatomical componentsallows the simulated uterus 32 to be pulled and manipulated and stillremain attached to the frame 34. A frame 34 made of semi-rigid foam mayalso move as the simulated uterus is being manipulated. A more rigidframe 34 would move less. The practitioner then divides the uteralsacralligaments 59. The practitioner then performs an anterior colpotomy intothe anterior cul-de-sac by incising the first sheet 38 simulating theperitoneum forming the vesico-uterine fold. The practitioner divides thetubo ovarian and round ligaments 61 on each side of the simulated uterus32. Due to the foam frame 34, the round and tubo ovarian ligaments 59remain realistically attached to the frame 34 after they have beendivided from the simulated uterus 32. The simulated uterus 32 is thenfreed and removed. The practitioner then practices to suture the vaginalcuff closed by passing a needle and suture through the tubular portion44 of the model 32 to close the vaginal canal 46 opening. Suturing thevaginal cuff in real surgery is another difficult part of the vaginalhysterectomy due to the space limitations. The tubular portion 44 thatis made of TPE holds the suture without tearing and limits the spaceallowed for instruments during the suturing process. The model 30 allowsthe practitioner to practice numerous difficult procedures on one model.

Turning now to FIGS. 7-8, a hysterectomy model 200 will now bedescribed. The model 200 includes a plurality of simulated organstructures 202 connected to and located inside a frame 204.

Turning now to FIG. 9, there is shown a frame 204 according to thepresent invention. The frame 204 is configured to simulate a pelvis andserve as a box-like encasement for housing the plurality of simulatedorgan structures 202. The frame 204 includes a top frame portion 206connected with fasteners 210 to a bottom frame portion 208. Theassembled frame 204 forms a base and a top interconnected by twoupstanding sidewalls and defines a central lumen with an open proximalend and an open distal end. The frame 204 has a flat base permitting itto be placed and stand on a flat surface.

Turning now to FIGS. 10-11, there is shown the top frame portion 206.FIG. 10 illustrates the top frame portion 206 in a flat arrangement. Thebottom side includes curvatures representative of the bony structure ofthe human pelvis and form the sidewalls and top of the frame 204. Fromthe flat arrangement, the top frame portion 206 is folded to form thefolded arrangement shown in FIG. 11. The top frame portion 206 includesa plurality of apertures 212 configured to receive fasteners forconnecting the plurality of simulated organ structures 202 to the frame204. Other apertures 212 are configured to pass the simulated organstructures through the apertures 212 and into the frame 204 forsupporting the various simulated organ structures such as simulatedvasculature with respect to the frame 204 as will be described ingreater detail below.

Turning now to FIGS. 12-13, there is shown a bottom frame portion 208.FIG. 12 illustrates the bottom frame portion 208 in a flat arrangementand FIG. 13 illustrates it in a folded arrangement. The bottom frameportion 208 defines the base of the frame 204 and includes curved endsthat simulate the bony anatomy of the human pelvis. The bottom frameportion 208 also includes a plurality of apertures 212 configured toconnect the plurality of simulated organ structures 202 to the frame 204with fasteners passed through the apertures and/or by passing thesimulated organ structures directly through the apertures 212 as will bedescribed in greater detail below.

Turning now to FIGS. 14-15, the plurality of simulated organ structures202 and its connection to the frame 204 will now be described. Theplurality of simulated organ structures 202 includes a simulated bladder214, a simulated uterus 216, a simulated vaginal canal 218, a simulatedrectum 220, a first sheet 222, a second sheet 224, a dissecting layer226 and a plurality of fasteners 210. The plurality of organ structures202 are interconnected as shown in FIG. 14 and in turn connected to theframe 204. Tubular shaped vasculature, ducts, arteries and the like inaddition to other simulated organs structures not mentioned herein maybe included in this model in an anatomically correct or anatomicallysimilar arrangement for the same or different anatomical location of thebody. Each simulated organ structure will now be described.

The simulated bladder 214 forms a closed receptacle with an outermembrane made of pink-colored silicone. The interior of the simulatedbladder 214 may be stuffed with polyfil or other material to maintainits shape. The simulated bladder 214 has a proximal end 240 and a distalend 242. The simulated uterus 216 is also made of silicone. Thesimulated uterus 216 has a proximal end 260 and a distal end 262. Thesimulated vaginal canal 218 is a tubular structure made of silicone andmay optionally contain an embedded mesh layer 230. The simulated vaginalcanal 218 has a proximal end 256 and a distal end 258. The simulatedrectum 220 is a tubular structure made of silicone with moldedtransverse folds. The simulated rectum 220 has a proximal end 244 and adistal end 246. Each of the first sheet 222 and the second sheet 224comprises a large flat planar layer of silicone material. Both sheets222, 224 represent the peritoneum. The first sheet 222 has a firstsurface 232 and a second surface 234 and a proximal end 248 and a distalend 250. The second sheet 224 has a first surface 236 and a secondsurface 238 and a proximal end 252 and a distal end 254.

With continued reference to FIGS. 14-15, the assembly, configuration andconnection of the plurality of simulated organ structures 202 will nowbe described. The distal end of the bladder 242 is attached to the firstsurface 232 of the first sheet 222 with adhesive approximately midwaybetween the proximal end 248 and the distal end 250 of the first sheet222 such that the first sheet 222 wraps around the distal end 242 of thesimulated bladder 214 from the top of the simulated bladder to thebottom of the simulated bladder 214. The first surface 232 is attachedto a fastener 210 near the distal end 248 of the first sheet 222. Thefirst sheet 222 is folded in an approximate U-shape such that the distalend 250 of the first sheet 222 and, in particular, the first surface 232of the first sheet 222, is attached to the simulated uterus 216 andattached to the simulated vaginal canal 218 via the dissecting layer 226using adhesive.

The dissecting layer 226 is a construct comprising a silicone layer 228interconnected with a fiber layer 229. While the silicone layer 228 isuncured, a fiber layer 229 is embedded to form the dissecting layer 226.The dissecting layer 226 is attached to the simulated vaginal canal 218in pieces or strips while the silicone of the simulated vaginal canal218 is still wet and uncured on a mandrel. When the dissecting layer 226is applied to the uncured simulated vaginal canal 218, the uncuredsilicone of the uncured simulated vaginal canal 218 is allowed to cureto attach the dissecting layer 226, in particular, to attach the fiberlayer 229 of the dissecting layer 226 to the simulated vaginal canal 218sandwiching the fiber layer 229 between two layers of silicone. Thedissecting layer 226 may be sectional around the simulated vaginal canal218 or completely tubular in shape to surround the circumference of thesimulated vaginal canal 218. Although the dissecting layer 226 is shownwith the same reference number, two dissecting layers 226 may beprovided on either side of the simulated vaginal canal 218 as shown inthe figures. Also, as shown in FIGS. 14-15, the dissecting layer 226 isattached to distal end 258 of the simulated vaginal canal 218. Thedissecting layer 226 is described in detail in co-pending InternationalPatent Application Serial No. PCT/US2016/041852 entitled “Simulateddissectible tissue” filed on Jul. 12, 2016 incorporated herein byreference in its entirety.

The second sheet 224 is attached between the simulated uterus 216 andthe simulated rectum 220. In particular, the first surface 236 at thedistal end 252 of the second sheet 224 is attached near the distal end262 of the simulated uterus 216. The second sheet 224 is attached alongthe length of the simulated uterus 216 toward the proximal end 260 usingadhesive. The second sheet 224 is attached to the dissecting layer 226.In particular, the first surface 236 of the second sheet 224 is attachedto the silicone layer 228 of the dissecting layer 226 using adhesive.Then, the second sheet 224 is folded to extend back towards the distalend of the simulated rectum 220 and attached along the top side andouter surface of the simulated rectum 220 such that the distal end 254of the second sheet 224 is near the distal end 246 of the simulatedrectum 220. The top side of the simulated bladder 214 is connected to afastener 210 and this fastener 210 is passed through an aperture 212 inthe top frame 206 of the frame 204. The proximal end 248 of the firstsheet 222 is also attached to a fastener 210 which is also passedthrough an aperture 212 in the top frame 206 of the frame 204 to attachthe plurality of the simulated organ structures 202 to the frame 204 ina suspended manner. While suspended from the top frame 204, theinterconnected plurality of simulated organ structures 202advantageously pendulate and move together in a realistic fashionwherein the point of contact with instruments and the like will movemost and simulated organs distal to the point of contact withinstruments move to a lesser degree. The bottom side of the simulatedrectum 220 is attached to at least two fasteners 210 as shown in FIGS.14-15. The two fasteners 210 are passed through apertures 212 in thebottom frame 208 to secure the plurality of simulated organ structures202 to the frame 202. Hence, the plurality of simulated organsstructures is spanned across the central opening of the frame 202 withthe first sheet 222 and second sheet 224 forming an interconnectingwebbing. The proximal end 260 of the simulated uterus 216 is insertedinto the distal end 258 of the simulated vaginal canal 218 and joinedtogether with adhesive. A simulated cervix is provided made of siliconeand located inside the simulated uterus 216 at the proximal end 260.

Turning now to FIG. 16, the fastener 210 will now be described ingreater detail. The fastener 210 has a dual-pronged, hooked, deflectableend 264 connected to a planar surface end 266. The two prongs of therivet-like fastener 210 extend from the planar surface 266. The twoprongs are resiliently deflectable toward and away from each other suchthat when passed through a smaller aperture, the prongs flex inwardlywhen ramped against the aperture and then spring back outwardly when thewidest portion of the prongs has passed through the aperture, thereby,snapping and hooking into the aperture wall. The fastener 210 is notlimited to having a two-prong arrangement. Instead, a single prong maybe employed having a bulbous portion for example that is configured tosnap through an aperture. A looped layer 268 of looped-sided VELCROhook-and-loop type fastener is attached to the planar end 266 withcyanoacrylate glue 270. After the layer of looped-side VELCROhook-and-loop type fastener is attached, a silicone layer 272 is appliedwhile uncured to the looped layer 268 making sure that the wet siliconeis spread into the loops of the looped layer 268. Then, the siliconelayer 272 is allowed to dry. Instead of a silicone layer 272, a layer ofsilicone adhesive may be used. The fastener 210 is easily attached to asilicone organ structure with adhesive or by putting a layer of wetsilicone onto the organ structure at a location where the fastener 210is desired to be located. The fastener 210 is then placed on the patchof wet uncured silicone and the patch is allowed to dry, adhering thesilicone embedded in the looped layer 268 to the silicone organstructure. In another variation, the silicone layer 272 is part of thesilicone organ structure as a patch of wet silicone or part of a curedsilicone component of the organ structure and attached with siliconeglue. The fasteners 210 are removable with respect to the frame 204 bypressing the prongs together and/or pushing the fastener 210 out of theapertures 212 making the plurality of simulated organ structures 202removable and replaceable with a new plurality of simulated organstructures 202 for continued practice and training of surgicalprocedures. The apertures 212 and fasteners 210 may be color-coded tomake attachment of the plurality of simulated organ structures 202 tothe frame 204 quick and easy.

Upon attachment, simulated vasculature 274, ducts, fallopian tubes,ureters or other anatomical or non-anatomical structure having atubular/cylindrical form and typically made of silicone are pulledthrough appropriately-sized apertures 212 as shown in FIGS. 7-8 tofurther support the connected simulated tissue structures. These tubularstructures have a free end and another end that is attached to othersimulated tissue structures. The free end is passed through an aperturein the frame and can be secured with adjustable length to adjust thetension on the simulated tissue structures to which it is connected. Forexample, a loose tension may be created by securing the tubularstructure with more slack between the frame and other simulated tissuestructure. Alternatively, tension on the simulated tissue may beincreased by pulling the tubular structure taunt with respect to theframe to create a relatively less pendulating simulated tissue constructwithin the frame. The tubular rope-like structure can be tied into aknot along its length to adjust the tension. The knot diameter is madelarger than the aperture in frame in order to secure the larger tissuestructure to the frame. The knots may be untied to remove the simulatedtissue structure or re-tied to provide a different tension level. Inanother variation, the tubular silicone simulated vasculature 274,ducts, fallopian tubes, ureters or other anatomical or non-anatomicalstructure having a tubular/cylindrical form are provided with rivets attheir distal end. The rivets include a distal end for connection withthe frame and a proximal portion embedded or swaged into the ends of thesilicone tubular structure to make a mechanical connection. Therivet-like fastener 210 serves as an interface connection between thesoft, pliable silicone of the simulated tissue structures and the rigidplastic frame. The simulated tissue structures are often made from roomtemperature vulcanized (RTV) silicone elastomers. As a result, thesimulated tissue structures are delicate and may tear easily if notreinforced. This makes it difficult to connect such artificial tissuestructures to the frame. The fastener has a rigid portion for connectingwith the rigid frame and an interfacing layer located between the rigidportion of the fastener and the attaching simulated tissue structure. Inone variation, the interfacing layer is a fiber layer that wet, uncuredsilicone may interpenetrate and when cured adhered securely theretoalong the area of the interfacing layer. The uncured silicone layer maybe a patch on the artificial tissue structure such that when cured, thepatch becomes integrally connected to the artificial tissue structureand to the interfacing layer. This type of fastener advantageouslyminimizes stress concentrations that would result in the fastenertearing away from the simulated tissue structure permitting thesimulated tissue structures to be manipulated aggressively. Thefasteners also permit a quick assembly of the simulated tissue structureinside the frame by simply snapping the fasteners through a plurality ofapertures in the frame. Disassembly is also facilitated and the frame isreusable after a simulated tissue structure is consumed with practicedand replaced with another simulated tissue model that is the same ordifferent from the discarded model. Advantageously, no additional toolsor adhesive is required for assembly. As an alternative to the fastenershown in FIG. 16, the first, second and/or third sheets 222, 224 and 225may be attached to the frame directly with adhesive. Although rivets aredescribed any suitable fastener adapted to secure the simulated tissuestructure to the frame is within the scope of the present invention.

Turning now to FIGS. 17-18, a transvaginal adapter 280 will now bedescribed. As described above, the transvaginal adapter 280 is formed asa leg 20 configured to support the top cover of the trainer 10. It isconfigured for simulating transvaginal surgery including transvaginalhysterectomies. The transvaginal adapter 280 includes a flat plate 282having an inner surface 284 for facing toward the interior of thetrainer and an outer surface 286 for facing outwardly towards the user.The plate 280 has a rectangular shape and includes an aperture 288passing through the plate 280 from the inner surface 284 to the outersurface 286. In one variation, the aperture 288 is circular in shape. Inanother variation, the aperture 288 is elongate elliptical, oval-like inshape and oriented vertically along the longitudinal axis of the adapter280. In another variation, the aperture 288 is elongate elliptical,oval-like in shape and oriented perpendicularly to the longitudinal axisof the adapter. The plate 280 also includes means such as tabs 290 or aU-shaped channel for inserting to connect the transvaginal adapter 280to the top cover 16 and to the base 18 to help support and space apartthe top cover 16. The transvaginal adapter 280 is located between thetop cover 16 and the base 18 and provides a side access aperture 288lateral to the trainer 10 or substantially perpendicular to the topcover 16 and the base 18. The plate 280 further includes a plurality ofmolding apertures 292, shown in FIGS. 23-28, surrounding or encompassingthe main aperture 288 configured for overmolding a soft simulatedvaginal tissue interface 294 made of silicone or the like. The method offorming the overmolded soft simulated vaginal tissue interface 294 willnow be described.

Turning now to FIG. 19, a mold 298 is provided. The mold 298 includes awell 298 encompassing an elongated center post 300. In anothervariation, the center post 300 is oval or circular in shape. Thecircular or oval shape will result in an opening having the same shapeand suitable for a TATME application in which the adapter is connectableto a simulated rectum and, thereby, serves as a transanal adapterinstead of a transvaginal adapter. A pre-made silicone tube 302 isplaced over the center post 300 as shown in FIG. 20. Next, turning toFIGS. 21-22, uncured silicone is poured into the well 298 to form theouter interface 304. Next, turning to FIGS. 23-24, the transvaginaladapter 280 is placed on top of the uncured silicone located inside thewell 298. The uncured silicone of the outer interface 304 is allowed tocure. Turning now to FIGS. 25-26, a backing mold 306 is placed aroundthe silicone tube 302 and inside the aperture 288. Uncured silicone isthen poured between the backing mold 306 and the inside of the aperture288 and into the molding apertures 292 and onto the inner surface 284and allowed to cure to form the inner interface 308 as shown in FIGS.27-28. The mold 296 and the backing mold 306 are removed. The resultingtransvaginal adapter 280 is shown in FIGS. 17-18. At least part of theflat plate 282 of the transvaginal adapter 280 is sandwiched between theinner interface 308 and the outer interface 304 as the wet silicone ofthe inner interface 308 adheres to the cured silicone of the outerinterface 304 through the aperture 288 and the molding apertures 292.The inner interface 308 and the outer interface 304 provide a soft andrealistic tissue appearance and feel. The transvaginal adapter 280 isconnected between the top cover 16 and base 18 of the trainer 10. Themodel 200 is placed inside the body cavity 12 of the trainer 10 andconnected to the transvaginal adapter 280 such that the silicone tube302 faces the interior of the cavity 12 and is inserted into theproximal end 256 of the simulated vaginal canal 218. The elongatedcenter post 300 of the mold 296 creates an elongated entry way leadinginto the model 200.

In use, a practicing surgeon may approach the simulated uterus 216 withsurgical instruments and retractors through the transvaginal adapter 280to perform a transvaginal hysterectomy. Alternatively, the simulateduterus 216 may be approached through the simulated abdominal wall of thetop cover 16 of the trainer 10. The user will practice laparoscopicsurgical skills, employing a trocar and scope to examine the anatomy andperform the simulated surgical hysterectomy. The procedure involvesmaking key incisions to detach the uterus and then remove it. Inparticular, the model 200 advantageously provides the one or moredissecting layer 226 that includes fibers embedded in silicone that makethe incisions and separation of the simulated uterus 216 realistic. Theuser may further practice suturing the simulated vaginal canal 218 afterremoval of the simulated uterus 216. For this purpose, the simulatedvaginal canal 218 is provided with an embedded mesh that makes itpossible for the silicone to hold sutures without easily tearing. Afteruse, the model 200 is removed from the trainer 10 and the plurality ofsimulated organ structures 202 is removed from the model 200 byreleasing the fasteners 212 from the frame 204. A new plurality ofsimulated organ structures 202 is then connected to the frame 204 andinserted into the trainer 10 for continued practice.

Turning now to FIGS. 29-30, another variation of the hysterectomy model200 will now be described. The model 200 is similar to the model 200described with respect to FIGS. 7-28 and like numbers will be used todescribe like parts. The model 200 includes a plurality of simulatedorgan structures 202 connected to and located inside a frame 204.

Turning briefly now to FIG. 31, there is shown a frame 204 according tothe present invention. The frame 204 is configured to simulate a pelvisand serve as a box-like encasement for housing the plurality ofsimulated organ structures 202. The frame 204 includes a top frameportion 206 connected with fasteners 210 to a bottom frame portion 208to form a top planar surface and a bottom planar surface interconnectedby two upstanding sidewalls. The top planar surface and the bottomplanar surface are parallel with each other and form corners with thesidewalls that are approximately 90 degrees. The sidewalls are angledtowards each such that at the proximal end the distance between thesidewalls is close and increases progressively with increasing distancetoward the distal end where the sidewalls are farther apart from eachother. The assembled frame 204 having a base and a top interconnected bytwo upstanding sidewalls defines a central lumen with an open proximalend and an open distal end. The area of the central lumen incross-section taken perpendicular to the longitudinal axis increasesprogressively with increasing distance from the proximal end toward thedistal end. The outer shape of the frame 204 can be dissimilar from theshape of the central lumen. Another example of a tapered frame that hasa central lumen with increasing area and that does not have corners is aframe that forms a frusto-conical shape. The central lumen of one suchvariation has a frusto-conical shape. The outer shape of the frame mayalso match the tapered shape of the central lumen. The frame 204 has aflat base permitting it to be placed and stand on a flat surface. In onevariation, the bottom frame portion 208 includes a first level and araised second floor 209 that raises the level of the model inside theframe 204 to be in line with the transvaginal adapter 280. The frame 204may include apertures 212 for passing of fasteners 210 and/or connectingtissue structures, such as vasculature, by passing them through theapertures and suspending them in the frame 204. The frame 204 of FIG. 31is similar to the frame 204 shown in FIGS. 7-13 in which the frame 204is comprised of folded plastic that is transparent and/or translucent.The folding of the plastic components of the frame 204 results cornersthat are representative of a pelvis that is not anatomically correct yetprovides advantages needed in simulating laparoscopic procedures inexchange for the realism of an anatomically correct pelvis. Theseadvantages include the mechanical constriction of organs located in thetapered proximal end having the smallest luminal cross-sectional area.The physical constriction of organs at the proximal end creates a morerigid response in the organs when manipulated by surgical instrumentsrelative to the distal end where organs located therein are lessconstricted and freer to pendulate and more fluidly respond tomanipulations with surgical instruments. The frame 204 of the presentinvention is an intentional simplification of the pelvis that combinesvariable resistance in the organs along the length of the longitudinalaxis of the central lumen. The smaller opening to the central lumen atthe proximal end of the frame is where the opening to the vaginal canalwould be positioned when the organs are placed inside the frame. Theproximal end of the frame is also oriented toward the transvaginal ortransanal adapted for connection therewith. The distal end of the frame204 is the location of the artificial uterus 216. The central lumen ofthe frame expands, widens and angles outwardly towards the distal end.This taper of the box-like frame widens relaxing the organs locatedtherein and the narrow proximal end constricts the organs, limiting therange of motion of the organs relatively more as a result of supportingthe organs in closer confines.

With reference back to FIGS. 29-30, the plurality of simulated organstructures 202 and its connection to the frame 204 will now bedescribed. The plurality of simulated organ structures 202 includes asimulated bladder 214, a simulated uterus 216, a simulated vaginal canal218, a simulated rectum 220, a first sheet 222, a second sheet 224, athird sheet 225 and a plurality of fasteners 210. The plurality of organstructures 202 are interconnected as shown in FIG. 29 and in turnconnected to the frame 204. Alternatively, the first sheet 222, secondsheet 224 and third sheet 225 are connected as shown in dotted lines inFIG. 29. In this variation, the first sheet 22 extends proximally alongthe top of the simulated bladder 214 and around the proximal end of thesimulated bladder 214 downwardly and toward the distal end of thesimulated bladder 214. In this variation, the simulated bladder 214 isnot suspended with a fastener 210 as shown in FIG. 29. The third sheet225 commences at the proximal end of the simulated bladder 214 andextends downwardly and is connected to the first sheet 222 at a location360 that in this variation comprises a location of adhesive connectingthe first sheet 222 and the third sheet 225. The second sheet 224 inthis alternative variation follows approximately the same path butincludes slit to pass the simulated uterus 216 through such that thesecond sheet 224 extends upwardly as shown with the dotted line. Tubularshaped vasculature, ducts, arteries and the like in addition to othersimulated organs structures not mentioned herein may be included in thismodel in an anatomically correct or anatomically similar arrangement forthe same or different anatomical location of the body. Each simulatedorgan structure will now be described.

The simulated bladder 214 forms a closed receptacle with an outermembrane made of pink-colored silicone. The interior of the simulatedbladder 214 may be stuffed with polyfil or other material to maintainits shape. The simulated bladder 214 has a proximal end 240 and a distalend 242.

The simulated uterus 216 is also made of silicone. The simulated uterus216 has a proximal end 260 and a distal end 262. The simulated uterus216 is made by providing a uterine mold 310 comprising two halves 310 a,310 b as shown in FIG. 32. A mesh fabric layer 312 is placed inside bothhalves the mold 310 a, 310 b. In one half of the mold 310 a, the meshfabric layer 312 is placed only in the proximal end of the mold 310 toreinforce that portion that will be subjected to the most force duringpractice of a surgical technique. The mesh fabric layer 312 may coverthe entire mold in one variation. The mesh fabric layer 312 includesdarts or cutouts to allow the fabric to lay as smoothly as possible inthe mold. Uncured silicone foam 314 is poured over the mesh fabric layer312 and into each half 310 a, 310 b of the mold 310 as shown in FIGS.33-34. The wet silicone foam 314 is spread evenly to contact all of thesurfaces to ensure that the silicone foam 314 will expand uniformly. Asshown in FIG. 35, a mandrel 316 is placed onto half 310 b the mold 310.The two halves 310 a, 310 b are placed together and the mold 310 isclamped as shown in FIGS. 36A and 36B and the silicone foam 314 isallowed to expand and cure. Upon curing, the mold 310 is removed fromthe cured silicone foam 314 and the mandrel 316 is mounted on a motorand the cured silicone foam is rotated and uncured silicone gel isapplied evenly onto the silicone foam 314 to create an outer layer ofsilicone that encompasses the silicone foam 314. The outer layer ofsilicone is allowed to cure and the mandrel 316 is removed leavingbehind a uterine-like form 332 shown in FIGS. 29-30 and 43-45. Next, asimulated cervix 318 is formed and inserted into the proximal end 260 ofthe cured foam and cured outer layer of silicone. The simulated cervix318 is formed by first providing a cervix mold 320 having a well 322 asshown in FIG. 37. The cervix mold 320 is generally made of two piecesthat are clamped together to define the well 322. A sleeve 324 of fabricsuch as KEVLAR synthetic fiber fabric is provided and inverted to createa fold 326 wherein the thickness of one end of the sleeve 324 is doubledas shown in FIGS. 38A, 38B and 39. The KEVLAR synthetic fiberreinforcement of the simulated cervix makes the portion of the cervixthat is pulled by the surgeon strong and allows the surgeon to use atenaculum with an ability to puncture and pull the simulated cervix asin real surgery without the model tearing. Also, at the same time, thefabric sleeve is compatible with silicone in that it does not inhibitthe curing of room temperature vulcanizing (RTV) silicone elastomersthat form the rest of the artificial cervix, uterus and vaginal canal.Because KEVLAR synthetic fiber is porous, it allows for a strongmechanical connection without additional adhesive and can be used withmaterials other than silicone. Any suitable fiber having a high tensilestrength-to-weight ratio may be employed. A post 328 is inserted intothe lumen of the fabric sleeve 324 such that it protrudes outwardly fromthe proximal end having the fold 326 as shown in FIG. 39. Thecross-section of the post 328 is elongate and narrow such that a woodenpopsicle stick can serve as the post 328. The sleeve 324 with the post328 is placed into the well 322 of the cervix mold 320 with the fold 326and protruding post 328 being placed into the bottom of the well 322 asshown in FIGS. 40 and 41B. Wet silicone 330 is poured into the well 322of the mold 320 such that approximately three quarters of the well 322is filled with uncured silicone 330 full as shown in FIGS. 41A and 42.The proximal end of the form 332 comprising the cured silicone foam witha coating of silicone is squeezed to substantially close the hole leftby the mandrel 316. The form 332 is squeezed to remove as much air aspossible from out of the inside of the form 332 as shown in FIG. 42 andwhile still squeezing the form 332, the proximal end of the form 332 isinserted into the wet silicone 330 inside the well 322 of the cervixmold 320 as shown in FIG. 43 and released. When the form 332 isreleased, a negative pressure is equalized moving wet silicone 330 intothe opening left by the removed mandrel 316 drawing wet silicone up intothe mandrel hole and into and around the fabric sleeve 324. The wetsilicone 330 inside the cervix mold 320 is allowed to cure and adhere tothe form 332 as shown in FIG. 44. The cervix mold 320 is removed leavingbehind the simulated uterus 216 that includes the form 332 comprisingthe silicone foam 314 and overcoat of silicone and the attachedsimulated cervix 334 at the proximal end as shown in FIG. 45. The post328 is removed to define a narrow opening 338 at the proximal end 260 ofthe simulated uterus 216 that is reinforced with the fabric sleeve 324as clearly seen in FIGS. 46A and 46B. The fabric sleeve 324advantageously reinforces that portion of the simulated uterus 216 thatis grasped strongly by the surgeon in practicing a hysterectomy. Thefabric sleeve 324 remains inside the simulated cervix 334. The fold 326in the sleeve 324 creates a smooth distal end such that individualthreads of the fabric sleeve 324 do not protrude from the cured siliconeat the proximal end 260 that would increase the chance of the sleeve 324ripping when pulled during surgical practice. Any flash is trimmed fromthe simulated cervix 334. In one variation, the well 322 of the cervixmold 320 is provided with a circumferential ledge that forms a ridge 336on the resulting simulated cervix 334. The ridge 336 is visible in FIG.45 and is useful for connection to the vaginal canal 218 which will bedescribed next.

Turning now to FIGS. 47-52, the simulated vaginal canal 218 will bedescribed. The simulated vaginal canal 218 is a tubular structure madeof silicone and may optionally contain an embedded mesh layer 230. Thesimulated vaginal canal 218 has a proximal end 256 and a distal end 258.The mesh layer 230 is formed into a tubular shape having an openproximal end. The mesh layer 230 in the form of a sock is placed onto amandrel 340 and attached with an elastic as shown in FIG. 47. Uncuredsilicone is applied onto the sock-like mesh layer 230 as the mandrel 240is rotated to form a thin layer of silicone that embeds the mesh layer230. The mesh layer 230 reinforcement advantageously prevents thepropagation of a tear in the silicone/and/or foam and makes theartificial uterus pliable and strong and not cut resistant. In onevariation, the mesh layer 230 can be made of KEVLAR para-aramidsynthetic fiber or poly-paraphenylene terephthalamide or othersubstantial equivalent known to a person skilled in the art. The uncuredsilicone is allowed to cure and the simulated vaginal canal 218 isremoved from the mandrel 240 as shown in FIG. 48. A hole 342 is punchedthrough the domed distal end 258 of the simulated vaginal canal 218 suchthat the hole 342 is substantially coaxial with the longitudinal axis ofthe simulated vaginal canal 218. The hole 342 is visible in FIG. 49. Thesimulated vaginal canal 218 is attached to the simulated uterus 216. Inparticular, the simulated cervix 334 is pushed through the hole 342 ofthe distal end 258 of the simulated vaginal canal 218 as shown in FIG.50. In particular, some adhesive is applied circumferentially around thesimulated cervix 334 in the location of the ridge 336 and the simulatedcervix 334 is pushed through the hole 342 until the ridge 336 justpasses through the hole 342. The ridge 336 facilitates holding thesimulated cervix 334 attached preventing it from easily backing out ofthe hole 342. The simulated vaginal canal 218 is inverted inside out andmore adhesive is applied at the interface of the simulated vaginal canal218 and simulated cervix 334 as shown in FIG. 51. FIG. 52 illustratesthe resulting attached simulated vaginal canal 218 and proximal end ofthe simulated cervix 334 with the opening 338. The simulated vaginalcanal 218 is enlarged to simulate a pre-retracted vaginal canal,allowing the user to practice with additional hands to aid inmaintaining the retraction. Furthermore, the domed distal end of thesimulated vaginal canal 218 that includes the hole 342 will invert asthe simulated cervix 334 is pulled proximally through the lumen of thesimulated vaginal canal 218 due to the dome effect and the adhesive.This feature advantageously closely represents what actually happensanatomically with real tissue.

The distal end 262 of the simulated uterus 216 may be provided withsimulated ovaries 344. The method of manufacturing simulated ovaries 344includes the step of providing an ovary mold 346 which is typically atwo-piece mold comprising two halves as shown in FIGS. 53 and 54. Themold 346 includes a well 348 that is shaped like an ovary. A cylindricalsilicone vessel 350 is provided inside the well 348 and inside channelsspanning across the mold 346. The silicone vessel 350 may be tied into aknot and the knot placed in the location of the ovary well 348 toprovide more structure to the resulting simulated ovary. The mold 346 isclosed and uncured silicone is then injected into the mold 346. Thesilicone is allowed to cure in the mold and around the silicone vessel350 become attached thereto. The mold 346 is opened and the simulatedovary 344 is removed and one end of the silicone vessel 350 is attachedwith adhesive to the simulated uterus 216 and other end of the siliconevessel is attached to the frame 204 by pulling the silicone vesselthrough one of the apertures 212 provided in the frame 204.

With reference back to FIGS. 29-30, the simulated rectum 220 is atubular structure made of silicone with molded transverse folds. Thesimulated rectum 220 has a proximal end 244 and a distal end 246. Eachof the first sheet 222, second sheet 224 and third sheet 225 comprises aflat planar layer of silicone material. Both sheets 222, 224 representthe peritoneum and the third sheet 225 represents a bladder flap orperitoneal reflection. The first sheet 222 has a first surface 232 and asecond surface 234 and a proximal end 248 and a distal end 250. A cutout(not shown) may be provided in from the distal end 250 such that thefirst sheet 222 does not overlap a portion of the simulated uterus 216.The second sheet 224 has a first surface 236 and a second surface 238and a proximal end 252 and a distal end 254. A cutout (not shown) may beprovided at the proximal end 252 of the second sheet 224 such that aportion of the simulated uterus 216 is not overlapped. The third sheet225 has a proximal end 352 and a distal end 354 and a first surface 356and a second surface 358.

With continued reference to FIGS. 29-30, the assembly, configuration andconnection of the plurality of simulated organ structures 202 will nowbe described. The distal end of the bladder 242 is attached to the firstsurface 232 of the first sheet 222 with adhesive approximately midwaybetween the proximal end 248 and the distal end 250 of the first sheet222 such that the first sheet 222 wraps around the distal end 242 of thesimulated bladder 214 from the top of the simulated bladder to thebottom of the simulated bladder 214. The proximal end of the bladder 240is attached to the first surface 356 of the third sheet 225 withadhesive such that the third sheet 225 wraps around the proximal end 240of the simulated bladder 214 from the top of the simulated bladder tothe bottom of the simulated bladder 214. The first sheet 222 and thethird sheet 225 come together at the bottom of the simulated bladder 214to contact a silicone webbing 360. In lieu of a silicone webbing 360,silicone glue is used to connect the two sheets 222, 225. The firstsurface 232 of the first sheet 222 is attached to a fastener 210 nearthe distal end 248 of the first sheet 222. The first sheet 222 is foldedin an approximate U-shape such that the distal end 250 of the firstsheet 222 and, in particular, the first surface 232 of the first sheet222, is attached to the simulated uterus 216 and attached to thesimulated vaginal canal 218 using adhesive. The third sheet 225 turnsaround at point 360 and backs over itself towards the proximal endcreating an overlap. In this location where the third sheet overlapsitself, the sticky silicone of the third sheet 225 will easily stickonto itself. Advantageously, this overlapping portion is what a surgeonwill practice separating when the surgeon approaches point 360 from theproximal end. In use laparoscopically, the surgeon will practicedelicately separating the overlap until point 360 is approached where asilicone membrane is formed by adhesive or other means. When point 360is reached, the surgeon will dissect the silicone membrane 360 to detachthe uterus. In use transvaginally, the surgeon will approach via thelumen of vaginal canal 218 and make a circumferential incision throughthe vaginal canal 218 and then detach the membrane 360. In doing so, thesurgeon will advantageously not notice the third sheet 225 which, inessence, is not anatomically correct, because the third sheet 225 isvery thin and is well-adhered to the vaginal canal and bladder. In onevariation, the third sheet 225 does not include surface texturing inorder to create a closer adherence to the vaginal canal and bladder. Inanother variation, the third sheet 225 is omitted. In such a variation,the bladder 240 is adhered to the vaginal canal 218 directly orindirectly via a fiber layer as shown in FIGS. 14-15.

The second sheet 224 is attached between the simulated uterus 216 andthe simulated rectum 220. In particular, the first surface 236 at thedistal end 252 of the second sheet 224 is attached near the distal end262 of the simulated uterus 216. The second sheet 224 is attached alongthe length of the simulated uterus 216 toward the proximal end 260 usingadhesive. The second sheet 224 is folded to extend back towards thedistal end of the simulated rectum 220 and attached along the top sideand outer surface of the simulated rectum 220 such that the distal end254 of the second sheet 224 is near the distal end 246 of the simulatedrectum 220. The top side of the simulated bladder 214 is connected to afastener 210 and this fastener 210 is passed through an aperture 212 inthe top frame 206 of the frame 204. The proximal end 248 of the firstsheet 222 is also attached to a fastener 210 which is also passedthrough an aperture 212 in the top frame 206 of the frame 204 to attachthe plurality of the simulated organ structures 202 to the frame 204 ina suspended manner. While suspended from the top frame 204, theinterconnected plurality of simulated organ structures 202advantageously pendulate and move together in a realistic fashionwherein the point of contact with instruments and the like will movemost and simulated organs distal to the point of contact withinstruments move to a lesser degree. The bottom side of the simulatedrectum 220 is attached to at least two fasteners 210 as shown in FIGS.29-30. The two fasteners 210 are passed through apertures 212 in thebottom frame 208 to secure the plurality of simulated organ structures202 to the frame 202. Hence, the plurality of simulated organsstructures is spanned across the central opening of the frame 202 withthe first sheet 222 and second sheet 224 forming an interconnectingwebbing. The proximal end 260 of the simulated uterus 216 is insertedinto the distal end 258 of the simulated vaginal canal 218 and joinedtogether with adhesive. The simulated cervix 334 is provided made ofsilicone and located inside the simulated uterus 216 at the proximal end260 as described above.

The fastener 210 is the same fastener 210 as described above withrespect to FIG. 16. Turning now to FIGS. 55-59, a transvaginal adapter280 will now be described. As described above, the transvaginal adapter280 is formed as a leg 20 configured to support the top cover 16 of thetrainer 10. It is configured for simulating transvaginal surgeryincluding transvaginal hysterectomies. The transvaginal adapter 280includes a flat plate 282 having an inner surface 284 for facing towardthe interior of the trainer and an outer surface 286 for facingoutwardly towards the user. The plate 280 has a rectangular shape andincludes an aperture 288 passing through the plate 280 from the innersurface 284 to the outer surface 286. In one variation, the aperture 288is circular in shape. In another variation, the aperture 288 is elongateelliptical, oval-like in shape and oriented vertically along thelongitudinal axis of the adapter 280. In another variation, the aperture288 is elongate elliptical, oval-like in shape and orientedperpendicularly to the longitudinal axis of the adapter. The plate 280also includes means such as tabs 290 or a U-shaped channel for insertingto connect the transvaginal adapter 280 to the top cover 16 and to thebase 18 to help support and space apart the top cover 16. Thetransvaginal adapter 280 is located between the top cover 16 and thebase 18 and provides a side access aperture 288 lateral to the trainer10 or substantially perpendicular to the top cover 16 and the base 18.The access aperture 288 is extra-large to simulate a pre-retractedvaginal canal as described above. The proximal end 256 of the simulatedvaginal canal 218 is stretched over the access aperture 288 at the innersurface 284 to connect the simulated vaginal canal 218 to the adapter280. The adapter advantageously secures the model in every axialdirection and serves as an interface for the surgeon. The adapter isalso not anatomically correct but advantageously permits use of realinstrumentation.

In use, a practicing surgeon may approach the simulated uterus 216 withsurgical instruments and retractors through the transvaginal adapter 280to perform a transvaginal hysterectomy. Alternatively, the simulateduterus 216 may be approached through the simulated abdominal wall of thetop cover 16 of the trainer 10. The user will practice laparoscopicsurgical skills, employing a trocar and scope to examine the anatomy andperform the simulated surgical hysterectomy. The procedure involvesmaking key incisions to detach the uterus and then remove it. Inparticular, the model 200 advantageously provides the first sheet 222and third sheet 225 and silicone webbing 360 that make the incisions andseparation of the simulated uterus 216 realistic. Also, the KEVLARsynthetic fiber mesh reinforced simulated cervix 334 prevents tearing ofthe silicone when being pulled. The user may further practice suturingthe simulated vaginal canal 218 after removal of the simulated uterus216. For this purpose, the simulated vaginal canal 218 is provided withan embedded mesh that makes it possible for the silicone to hold sutureswithout easily tearing. After use, the model 200 is removed from thetrainer 10 and the plurality of simulated organ structures 202 isremoved from the model 200 by releasing the fasteners 212 from the frame204. A new plurality of simulated organ structures 202 is then connectedto the frame 204 and inserted into the trainer 10 for continuedpractice.

Any portion of the model can be made of one or more organic base polymerincluding but not limited to hydrogel, single-polymer hydrogel,multi-polymer hydrogel, rubber, latex, nitrile, protein, gelatin,collagen, soy, non-organic base polymer such as thermo plasticelastomer, Kraton, silicone, foam, silicone-based foam, urethane-basedfoam and ethylene vinyl acetate foam and the like. Into any base polymerone or more filler may be employed such as a fabric, woven or non-wovenfiber, polyester, nylon, cotton and silk, conductive filler materialsuch as graphite, platinum, silver, gold, copper, miscellaneousadditives, gels, oil, cornstarch, glass, dolomite, carbonate mineral,alcohol, deadener, silicone oil, pigment, foam, poloxamer, collagen,gelatin and the like. The adhesives employed may include but are notlimited to cyanoacrylate, silicone, epoxy, spray adhesive, rubberadhesive and the like.

It is understood that various modifications may be made to theembodiments and variations disclosed herein. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of preferred embodiments. Those skilled in the art willenvision other modifications within the scope and spirit of the presentdisclosure.

We claim:
 1. A surgical simulator for surgical training comprising: aframe having an inner surface and an outer surface defining a frame walltherebetween; the inner surface defines a central lumen extending alonga longitudinal axis of the frame; the central lumen having at least oneof a proximal opening and a distal opening; wherein the frame isconfigured to removably receive at least one artificial tissue structurewithin the lumen such that the at least one artificial tissue structureis at least partially suspended within the central lumen and at leastpartially encompassed by the frame wall along the central lumen; the atleast one artificial tissue structure being suspended with fastenersconfigured to connect the at least one artificial tissue structure tothe frame wall; wherein the central lumen has a cross-sectional areataken perpendicular to the longitudinal axis; wherein thecross-sectional area progressively increases from the proximal end tothe distal end.
 2. The surgical simulator of claim 1 further includingat least one artificial tissue structure an organ lumen having anopening at a proximal end; the organ lumen being positioned such thatthe opening is facing the proximal opening of the frame.
 3. The surgicalsimulator of claim 1 further including at least one artificial tissuestructure suspended within the frame along the longitudinal axis suchthat the at least one artificial tissue structure is permitted topendulate more at the distal end relative to the proximal end.
 4. Thesurgical simulator of claim 1 wherein the frame has a frusto-conicalshape.
 5. The surgical simulator of claim 1 wherein the frame wall has aplanar top wall that is substantially parallel to a planar bottom wall;the top wall and the bottom wall being interconnected by two planarsidewalls convergently angled toward the proximal end.
 6. The surgicalsimulator of claim 5 wherein the planar sidewalls are substantiallyperpendicular to the top wall and the bottom wall.
 7. The surgicalsimulator of claim 1 further including one or more artificial tissuestructures selected from the group consisting of at least one of asimulated uterus, vaginal canal, cervix, fallopian tubes, bladder,rectum, and peritoneum.
 8. The surgical simulator of claim 1 furtherincluding a laparoscopic trainer having top cover and a base defining acavity therebetween; the trainer having at least one aperture betweenthe top cover and the base; the aperture being configured to attach andprovide access to the organ lumen.
 9. The surgical simulator of claim 1further including at least one artificial tissue structure locatedinside the frame and increasingly laterally constricted along thelongitudinal axis of the frame from the distal end to the proximal end.10. The surgical simulator of claim 1 wherein the fasteners include aproximal end connected to the at least one simulated tissue structureand a distal end configured for attachment to the frame.
 11. Thesurgical simulator of claim 10 wherein the distal ends of the fastenersare sized and configured for a friction fit engagement with a pluralityof apertures formed in the frame wall.
 12. A surgical simulator forsurgical training comprising: a frame having an inner surface and anouter surface defining a frame wall therebetween; the inner surfacedefines a central lumen extending along the longitudinal axis; thecentral lumen having at least one of a proximal opening and a distalopening and a top and a bottom; an artificial uterus; an artificialvaginal canal defining an opening at the proximal end and connected tothe artificial uterus at the distal end; an artificial rectum having alumen defining a proximal opening; an artificial bladder; a first planarsheet of silicone having a first surface and a second surface defining athickness therebetween; and a second planar sheet of silicone having afirst surface and a second surface; wherein the artificial uterus,artificial vaginal canal, and artificial bladder are connected to thefirst surface of the first planar sheet and the first planar sheet beingconnected to the top of the central lumen; wherein the artificial uterusand artificial vaginal canal are connected to the artificial rectum bythe second planar sheet; and wherein the artificial rectum is connectedto the bottom of the frame.
 13. The surgical simulator of claim 12wherein the artificial bladder is connected to the top of the frame. 14.The surgical simulator of claim 12 further including a third planarsheet of silicone having a first surface and a second surface; whereinthe third planar sheet is connected to the artificial bladder and theartificial vaginal canal.
 15. The surgical simulator of claim 14 whereinthe third planar sheet is connected to the first sheet at a locationbetween the artificial bladder and the artificial vaginal canal.
 16. Thesurgical simulator of claim 12 wherein the artificial uterus issuspended within the central lumen by the first planar sheet.
 17. Thesurgical simulator of claim 12 wherein the artificial uterus ispermitted to pendulate within the central lumen.
 18. The surgicalsimulator of claim 12 wherein the first planar sheet defines a fold theproximal end and the second planar sheet defines a fold at the proximalend.
 19. An artificial uterus for surgical training, comprising: abulbous body at a distal end; and a simulated cervix at a proximal end;the simulated cervix being made of silicone and defining an opening atthe proximal end; wherein the simulated cervix includes a reinforcementmade of mesh material; the mesh material having a plurality ofinterwoven filaments forming a tubular structure having a first end anda second end; the tubular structure having a first layer of meshmaterial being folded to create a fold at a proximal end such that thefirst end and the second end are distal to the fold; the folded tubularstructure forming a tubular second layer of mesh material substantiallycoaxial with the tubular first layer of mesh material; the foldedtubular structure being embedded in silicone of the simulated cervix atthe proximal end.
 20. The artificial uterus of claim 19 wherein the foldat the proximal end of the reinforcement is substantially coincidentwith the proximal end of the simulated cervix and encompasses theartificial cervical opening with the first and second ends of thetubular structure extending distally from proximal opening.